UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009092 |
|---|---|
| Receipt number | R000010666 |
| Scientific Title | A Feasibility Study of Induction Pemetrexed plus Cisplatin Followed by Pleurectomy/Decortication aimed at Macroscopic Complete Resection for Malignant Pleural Mesothelioma |
| Date of disclosure of the study information | 2012/10/12 |
| Last modified on | 2013/04/12 00:15:51 |
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Basic information
Public title
A Feasibility Study of Induction Pemetrexed plus Cisplatin Followed by Pleurectomy/Decortication aimed at Macroscopic Complete Resection for
Malignant Pleural Mesothelioma
Acronym
A Feasibility Study of Induction Pemetrexed plus Cisplatin Followed by Pleurectomy/Decortication aimed at Macroscopic Complete Resection for
Malignant Pleural Mesothelioma
Scientific Title
A Feasibility Study of Induction Pemetrexed plus Cisplatin Followed by Pleurectomy/Decortication aimed at Macroscopic Complete Resection for
Malignant Pleural Mesothelioma
Scientific Title:Acronym
A Feasibility Study of Induction Pemetrexed plus Cisplatin Followed by Pleurectomy/Decortication aimed at Macroscopic Complete Resection for
Malignant Pleural Mesothelioma
Region
| Japan |
Condition
Condition
Malignant pleural mesothelioma
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the feasibility of multimodality therapy for resectable malignant pleural mesothelioma, comprised induction pemetrexed plus cisplatin followed by pleurectomy/decortications (P/D) aim at macroscopic complete resection (MCR).
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MCR rate by P/D or extrapleural pneumonectomy
Key secondary outcomes
-P/D rate
-MCR rate by P/D
- Overall survival time
-Pulmonary function at three months after surgery
-Adverse event rate
-Treatment related mortality
-Response rate of induction chemotherapy
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Induction chemotherapy consists of 3 courses, and one course lasts 21 days.
500mg/m2 of pemetrexed and 60mg/m2 of cisplatin are administered intravenously on the day 1 of each course.
After induction chemotherapy, P/D is conducted to remove all gross tumor of pleura.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Pathologically proved malignant pleural mesothelioma
2) Completely resectable disease
3) T0-3, N0-2, M0
4) Measurable disease not mandatory
5) No prior therapy for mesothelioma
6) Age : 20 - 75 years
7) Performance status of 0-1 (ECOG)
8) Predicted forced expiratory volume at 1 second after extrapleural pneumonectomy: 1L or greater
9) Adequate major organ function
10) Patients with an estimated life expectancy of more than 12 weeks
11) Written informed consent
Key exclusion criteria
1) Serious or uncontrolled complication
2) Uncontrolled hypertension or diabetes mellitus
3)Active systemic infection
4) Active concomitant malignancy
5)With prior unapproved drugs or investigational new drugs
6) With a history of sensitivity to platinum agent, folic acid or vitamin B12
7) Women with confirmed, lactating or suspected pregnancy. Patients who won't avoid pregnancy.
8) Peripheral neuropathy (grade 2 or greater)
9) Interstitial pneumonia or pulmonary fibrosis on chest-X ray
10) Medically endorsed anticonception can't be assured till 90 days after the final administration
11) Inappropriate patients for entry on this trial in the judgment of the investigator.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Nakano |
Organization
Hyogo College of Medicine
Division name
Division of Respiratory Medicine, Department of Internal Medicine
Zip code
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo 663-8501, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Seiki Hasegawa |
Organization
Hyogo College of Medicine
Division name
Department of Thoracic Surgery
Zip code
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo 663-8501, Japan
TEL
0798-45-6885
Homepage URL
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2012 | Year | 08 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 10 | Month | 11 | Day |
Last modified on
| 2013 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010666
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| Registered date | File name |
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